Date: 2017-03-01
Type of information: Results
phase: 2b
Announcement: results
Company: Aurinia Pharmaceuticals (Canada)
Product: voclosporin
Action mechanism: calcineurin inhibitor/immunosuppressive agent. Voclosporin is a novel and potentially best-in-class calcineurin inhibitor with clinical data in over 2,200 patients across indications. Voclosporin is an immunosuppressant, with a synergistic and dual mechanism of action. By inhibiting calcineurin, voclosporin blocks IL-2 expression and T-cell mediated immune responses. It is made by a modification of a single amino acid of the cyclosporine molecule which has shown a more predictable pharmacokinetic and pharmacodynamic relationship, an increase in potency, an altered metabolic profile, and potential for flat dosing. Aurinia Pharmaceuticals anticipates that upon regulatory approval, patent protection for voclosporin will be extended in the United States and certain other major markets, including Europe and Japan, until at least October 2027 under the Hatch-Waxman Act and comparable laws in other countries.
Disease: lupus nephritis
Therapeutic area: Autoimmune diseases – Inflammatory diseases - Renal diseases
Country: Bangladesh, Belarus, Bulgaria, China, Ecuador, Georgia,Guatemala, Republic of Korea, Mexico, Philippines, Poland, Russian Federation, Serbia, Singapore, Spain, Sri Lanka, Taiwan, Thailand, Ukraine, USA
Trial details: The AURA–LV study (Aurinia Urinary protein Reduction in Active Lupus with Voclosporin) is a 48-week study comparing the efficacy of two doses of voclosporin added to current standard of care of mycophenolate mofetil (MMF) against standard of care with placebo in achieving CR in patients with active lupus nephritis. All arms also received low doses of corticosteroids as background therapy. 265 patients were enrolled at centers in 20 countries worldwide. On entry to the study, patients were required to have a diagnosis of LN according to established diagnostic criteria (American College of Rheumatology) and clinical and biopsy features indicative of highly active nephritis. (NCT02141672)
Latest
news: • On March 1, 2017, Aurinia Pharmaceuticals announced results from its Phase IIb AURA-LV study in lupus nephritis. At 48
weeks, the trial met the complete and partial remission (CR/PR) endpoints, demonstrating statistically significantly greater CR and PR in patients in both low dose (23.7mg of voclosporin twice daily (p<.001)) and high dose (39.5mg twice daily (p=.026)) cohorts versus the control group. Each arm of the study included the current standard of care of mycophenolate mofetil (MMF) as background therapy and a forced steroid taper to 5mg/day by week 8 and 2.5mg by week 16. No unexpected safety signals were observed and there were no additional deaths in the voclosporin treated patients; however, there were three deaths and one malignancy reported in the control arm after completion of the study treatment period.
Additional data analyses for the AURA study at 48 weeks will be released at future corporate, medical and scientific meetings.
The 24 and 48-week top-line efficacy results are summarized below: Complete
Remission
*All p-values are vs control
Endpoint
Treatment
24 weeks
Odds ratio
P-value*
48 weeks
Odds Ratio
P-value*
23.7mg VCS BID
33%
2.03
p=.045
49%
3.21
p<.001
39.5mg VCS BID
27%
1.59
p=.204
40%
2.10
p=.026
Control Arm
19%
NA
NA
24%
NA
NA
Partial Remission
23.7mg VCS BID
70%
2.33
p=.007
68%
2.34
p=.007
39.5mg VCS BID
66%
2.03
p=.024
72%
2.68
p=.002
Control Arm
49%
NA
NA
48%
NA
NA
